Pharmaceutical & API manufacturing sites in Romania

6 drug establishments in Romania are registered with the US FDA; 2 (33%) list API manufacture among their operations. 5 registrant companies are identified; sites whose registrant is not resolved to a company profile are not counted. 6 published sites are matched to an EU or UK GMP certificate inspected within the last three years.

Counts are physical site addresses in the FDA's current establishment register (US-facing sites only), not headquarters and not production volume. Methodology

FDA-registered sites
6
Registered for API manufacture
2
Identified registrants
5
Current EU/UK GMP match
6

Registered operations

Analytical testing5
Drug manufacture5
Packaging3
API manufacture2
Labelling2
Sterilisation1

A site can register several operations, so these do not add up to the site total.

Companies headquartered in Romania

API manufacturing sites (2)

Other sites with EU/UK GMP documents (4)

Only sites registered with the US FDA appear, so manufacturing that serves only other markets is missing and these figures understate national capacity. A GMP match requires the certificate address to name the site's street and its city or postcode; an unmatched site is not an uncertified site.